News Tagged ‘serious adverse events

Black box warning on Reglan came too late for some

black box warning Black box warning on Reglan came too late for someMetoclopramide, known by the brand name Reglan, is one of the leading medications prescribed to treat gastroesophageal reflux disease (GERD) and gastroparesis, a condition in which the stomach takes too long to empty its contents. What many don’t know is that was first used to treat psychosis in patients, but it was found to show more promise as a drug to treat gastrointestinal disorders. Unfortunately, like many medications used to treat psychosis, also increased one’s risk of developing a severe movement disorder known as Tardive Dyskinesia.

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Ruling: patients may sue generic drug makers under state law

judge gavelThe U.S. Fifth Circuit Court of Appeals has found in favor with a lower court that patients may sue generic drug makers under state law for failing to provide adequate warnings about potential side effects with their drugs. The ruling extends a 2009 U.S. Supreme Court ruling governing makers of name-brand drugs. The issue of whether generic drug companies should be held liable for not adequately warning consumers has divided several district courts, which can increase the odds of a Supreme Court review in the future, according to U.S. Circuit Judge Patrick Higginbotham.

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